cromolyn sodium (Rx)

Brand and Other Names:Gastrocrom
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral concentrate

  • 100mg/5mL

Mastocytosis

200 mg PO four times daily; 30 minutes prior to meals; may increase to 40 mg/kg/day if control of symptoms not seen within 2-3 weeks  

Food Allergy & Inflammatory Bowel Disease (Off-label)

200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily

Administration

Dilute contents of ampule with glass of water; stir well

For systemic mastocytosis administer 30 minutes before meals and bedtime

For food allergy and inflammatory bowel disease administer 15-20 minutes before meals

Dosage Forms & Strengths

oral concentrate

  • 100mg/5mL

Mastocytosis

<2 years: Safety and efficacy not established

2-12 years: 100 mg PO four times daily; not to exceed 40 mg/kg/day; give 30 minutes AC and HS  

>12 years: As in adults; 200 mg PO four times daily; 30 minutes prior to meals; may increase to <40 mg/kg/day if control of symptoms not seen within 2-3 weeks

Food Allergy & Inflammatory Bowel Disease (Off-label)

<2 years old: Not recommended

2-12 years: 100 mg four times daily initially; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 40 mg/kg/day  

>12 years: 200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily

Administration

Dilute the contents of ampule with glass of water

For systemic mastocytosis administer 30 minutes before meals and bedtime

For food allergy and inflammatory bowel disease administer 15-20 minutes before meals

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Adverse Effects

Frequency Not Defined

Diarrhea

Headache

Angioedema

Premature ventricular contractions

Hypoesthesia

Lightheadedness

Flushing

Palpitation

Erythema

Postprandial

Photosensitivity

Behavior changes

Psychosis

Esophagospasm

Nausea

Abdominal pain

Pancytopenia

Polycythemia

Stomatitis

Neutropenia

Rash

Pruritus

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Warnings

Contraindications

Hypersensitivity

Cautions

Severe anaphylactic reactions may occur (rare)

Excreted through biliary and renal routes; monitor closely patients with hepatic/renal insufficiency; decrease dose in patients with impaired renal or hepatic function

Use caution in patients with history of cardiac arrhythmia and hepatic or renal impairment

Oral concentrated solution should not be used for inhalation or injection

Not beneficial in the acute setting

Symptoms may reoccur when tapering or withdrawing the drug; use caution

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown if excreted in breast milk, use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Mast cell stabilizer; inhibits release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis from mast cell by inhibiting degranulation following exposure to reactive antigens

Pharmacokinetics

Bioavailability: 0.5-2%

Peak plasma time: 15 min

Peak plasma concentration: 9 ng/mL

Half-life: 80-90 min

Onset: 2-6 weeks (PO)

Duration: 6 hr

Excretion: Feces (98%, unabsorbed drugs); urine (<0.5%)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
cromolyn nasal
-
5.2 mg/spray (4 %) aerosol
cromolyn inhalation
-
20 mg/2 mL nebulizer soln
Nasalcrom nasal
-
5.2 mg/spray (4 %) aerosol
Gastrocrom oral
-
100 mg/5 mL liquid
Gastrocrom oral
-
100 mg/5 mL liquid
cromolyn ophthalmic (eye)
-
4 % drops
cromolyn ophthalmic (eye)
-
4 % drops
cromolyn oral
-
100 mg/5 mL liquid
cromolyn oral
-
100 mg/5 mL liquid
cromolyn oral
-
100 mg/5 mL liquid
cromolyn oral
-
100 mg/5 mL liquid

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
cromolyn nasal

CROMOLYN - NASAL

(CROW-mow-lin)

COMMON BRAND NAME(S): Nasalcrom

USES: This medication is used to prevent allergic symptoms in the nose. It reduces stuffy/runny nose, mucus dripping into the back of the throat, itching, and sneezing caused by seasonal allergies (hay fever) and other allergens (e.g., dust mites, pet dander). This medication is not an antihistamine and does not provide immediate relief from allergic symptoms. It should be used before contact with the allergen.Cromolyn is known as a mast cell stabilizer. It works by preventing the release of certain natural substances (histamine, SRS-A) made by the body that cause allergy symptoms.Do not use this medication to treat sinus infection, asthma, or cold symptoms.

HOW TO USE: Follow all directions on the product package, or use as directed by your doctor. If you have any questions, ask your doctor or pharmacist.Use 1 spray in each nostril, usually every 4 to 6 hours (3 to 4 times a day) or as directed by your doctor. Do not use more than 6 times a day. Use every day you are around allergens (e.g., during pollen season).Gently blow your nose before using this drug. If nasal passages are blocked, a nasal decongestant may be used first to open the passages. Use your finger to close the nostril on the side not receiving the medication. While keeping your head upright, place the spray tip into the open nostril. Spray the medication into the open nostril as you breathe in through your nose. Sniff hard a few times to be sure the medication reaches deep into the nose. Repeat these steps for the other nostril.Avoid spraying the medication into your eyes. Rinse the spray tip with hot water or wipe with a clean tissue after each use. Make sure that water does not get inside the container. Replace cap after each use.This medication does not work right away. It must be used regularly to be most effective. It may take 1 to 2 weeks of regular use to get the full benefit. If your condition persists or worsens after 2 weeks, or if you think you may have a serious medical problem, stop using this medication and seek immediate medical attention. Talk with your doctor if you are still using this medication after 12 weeks.

SIDE EFFECTS: This medication may cause brief stinging/sneezing right after use. If these effects persist or worsen, tell your doctor promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Stop using this medication and tell your doctor right away if any of these rare but very serious side effects occur: frequent nosebleeds, sores in the nose, wheezing/chest tightness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to cromolyn; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.If you have any of the following health problems, consult your doctor or pharmacist before using this product: asthma, growths in the nose (nasal polyps).If you are using this medication for self-treatment, tell your doctor before using this medication if you have any of the following symptoms: fever, yellow/green/discolored fluid from the nose, sinus pain, wheezing.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Doing so may cause the spread of germs.Avoid allergens that may be the cause of your allergies. Some common allergens include molds, pollen, grasses, weeds, dust mites, and pet dander. This medication works better if started a week before you expect to be exposed to allergens (e.g., a week before your seasonal allergy symptoms usually start).

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Refer to storage information printed on the package. Store at room temperature between 68-77 degrees F (20-25 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.